Volume 17, Issue 39, January - June, 2023

Analytical quality by design used in the pharmaceutical industry: A review

Khagga Bhavya Sri^1♦, Saba Fatima², Mogili Sumakanth³

¹Department of Pharmaceutical Analysis, HOD of Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India
²Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India
³Department of Pharmaceutical Chemistry, Principal at RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India

^♦Corresponding author
Department of Pharmaceutical Analysis, HOD of Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Hyderabad, Telangana, India

ABSTRACT

During the previous decade, the pharmaceutical industry has grown quickly as a result of its focus on product safety, quality and efficacy. By utilizing numerous scientific methods like QbD (Quality by Design) and PAT (Process Analytical Technology), various pharmaceutical companies expanded the quantity of products they were developing. The use of QbD in the creation of formulations and the API synthesis process has been covered in detail in ICH recommendations Q8 to Q11. The QbD technique for the synthesis of APIs was explicitly explained in the ICH Q11 guidelines with examples. The QbD technique is being used by generic businesses to design formulations and from the USFDA's standpoint, it is even required. As of the right moment, none of the regulatory bodies have any standards for AQbD and PAT in analytical development. The ATP-Analytical Target Profile, CQA-Critical Quality Attributes with risk assessment, MODR-Method Operable Design Region, DoE-Design of Experiments and Control Strategy with Risk Assessment, Method Validation, CMM-Continuous Method Monitoring and Continuous Improvement are the AQbD tools.

Keywords: QbD technique, ICH guidelines, Process Analytical Technology, AQbD

Drug Discovery, 2023, 17(39), e22dd1930

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DOI: https://doi.org/10.54905/disssi.v17i39.e22dd1930

Published: 11 May 2023